Allergy and Infectious Diseases Research
To assist public and private nonprofit institutions and individuals to establish, expand and improve biomedical research and research training in infectious diseases and related areas; to conduct developmental research, to produce and test research materials. To assist public, private and commercial institutions to conduct developmental research, to produce and test research materials, to provide research services as required by the agency for programs in infectious diseases, and controlling disease caused by infectious or parasitic agents, allergic and immunologic diseases and related areas. Projects range from studies of microbial physiology and antigenic structure to collaborative trials of experimental drugs and vaccines, mechanisms of resistance to antibiotics as well as research dealing with epidemiological observations in hospitalized patients or community populations and progress in allergic and immunologic diseases. Because of this dual focus, the program encompasses both basic research and clinical research. Small Business Innovation Research (SBIR) program expands and improves private sector participation in biomedical research. The SBIR Program intends to increase and facilitate private sector commercialization of innovations derived from Federal research and development; to increase small business participation in Federal research and development; and to foster and encourage participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation. The Small Business Technology Transfer (STTR) program stimulates and fosters scientific and technological innovation through cooperative research and development carried out between small business concerns and research institutions; to foster technology transfer between small business concerns and research institutions; to increase private sector commercialization of innovations derived from Federal research and development; and to foster and encourage participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation. Research Career Development Awards support the development of scientists during the formative stages of their careers. Individual National Research Service Awards (NRSAs) are made directly to approve applicants for research training in specified biomedical shortage areas. In addition, Institutional National Research Service Awards are made to enable institutions to select and make awards to individuals to receive training under the aegis of their institutional program.
General information about this opportunity
Last Known Status
Agency: Department of Health and Human Services
Office: National Institutes of Health
Type(s) of Assistance Offered
Public Health Service Act, Title IV, Section 301; Small Business Research and Development Enhancement Act of 1992, 42 U.S.C 241.
Who is eligible to apply/benefit from this assistance?
Universities, colleges, hospitals, laboratories, and other public or private nonprofit domestic institutions, including State and local units of government, and individuals are eligible to make application for grant support of research by a named principal investigator or a research career development candidate. For-profit organizations are also eligible, with the exception of NRSA. Individual NRSA awardees must be nominated and sponsored by a public or nonprofit private institution having staff and facilities appropriate to the proposed research training program. All NRSA awardees must be citizens or have been admitted to the United States for permanent residence. To be eligible, predoctoral candidates must have completed the baccalaureate degree, and postdoctoral awardees must have a professional or scientific degree (M.D., Ph.D., D.D.S., D.O., D.V.M., Sc.D., D.Eng., or equivalent domestic or foreign degree). SBIR grants can be awarded only to domestic small businesses (entities that are independently owned and operated for profit, are not dominant in the field in which research is being proposed and have no more than 500 employees). Primary employment (more than one-half time) of the principal investigator must be with the small business at the time of award and during the conduct of the proposed project. In both Phase I and Phase II, the research must be performed in the U.S. or its possessions. STTR grants can be awarded only to domestic small business concerns (entities that are independently owned and operated for profit, are not dominant in the field in which researches proposed and have no more than 500 employees) which "partner" with a research institution in cooperative research and development. At least 40 percent of the project is to be performed by the small business concern and at least 30 percent by the research institution. In both Phase I and Phase II, the research must be performed in the U.S. and its possessions. To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council.
Any nonprofit or for-profit organization, company, or institution engaged in biomedical research.
Research grant applicants must define the objectives, methodology, and facilities for the program, and must present the program director's competence and scientific interest. For SBIR and STTR grants, applicant organization (small business concern) must present in a research plan an idea that has potential for commercialization and furnish evidence that scientific competence, experimental methods, facilities, equipment, and funds requested are appropriate to carry out the plan. Grant forms PHS 6246-1 and PHS 6246-2 are used to apply for SBIR Phase I and Phase II, respectively. Grant forms PHS 6246-3 and PHS 6246-4 are used to apply for STTR Phase I and Phase II, respectively. Applicants for individual NRSAs must include their academic record, research experience, citizenship, institute sponsorship, and the proposed area and plan of training in their applications. The applicant for an institution must specify the objectives, methodology, and resources for the research training program, the qualifications experience of directing staff, the criteria to be used in selecting individuals for award, and a detailed budget justification for the amount of grant funds requested. For-profit organizations' costs are determined in accordance with Subpart 31.2 of the Federal Acquisition Regulations. For other grantees, costs will be determined by HHS Regulations 45 CFR, Part 74, Subpart Q. 2 CFR 200, Subpart E - Cost Principles applies to this program.
What is the process for applying and being award this assistance?
Preapplication coordination is not applicable. Environmental impact information is not required for this program. This program is excluded from coverage under E.O. 12372.
This program is excluded from coverage under 2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards. NIH has transitioned to the SF424 family of forms and electronic submission through Grants.gov for most research programs and funding mechanisms. All applications must be submitted in response to a specific funding opportunity announcement (FOA). The FOA will specify which forms should be used for submission. Application forms and information concerning current areas of science being supported are available from the Division of Extramural Outreach and Information Resources, Office of Extramural Research, National Institutes of Health, 6701 Rockledge Drive, Room 6207, MSC 7910, Bethesda, MD 20892-7910. Telephone: (301) 435-0714. Fax: (301) 480-0525. E-mail: email@example.com. The standard application forms, as furnished by PHS and required by 45 CFR Part 92, must be used for this program. This program is subject to the provisions of 45 CFR, Part 92 for State and local governments and OMB Circular No. A-110 for nonprofit organizations. Completed applications should be submitted to the Center for Scientific Review, National Institutes of Health, Bethesda, MD 20892. SBIR and STTR Grant Solicitations and SBIR Contract Solicitation may be obtained electronically through the NIH's "Small Business Funding Opportunities" homepage at www.nih.gov/grants/funding/sbir.htm on the World Wide Web. A limited number of hard copies of these publications are produced. Subject to availability, they may be obtained by contacting the NIH support services contractor: telephone: (301) 206-9385; fax: (301) 206-9722; E-mail: firstname.lastname@example.org. The Solicitations include submission procedures, review considerations, and grant application or contract proposal forms. SBIR and STTR grant applications should be submitted to the Center for Scientific Review, 6701 Rockledge Drive, Room 1040 - MSC 7710, Bethesda, MD 20892-7710.
All accepted applications are reviewed for scientific merit by an appropriate initial review group and a national advisory council. If recommended for approval and a decision to make an award is made, a formal award notice will be sent to the applicant and applicant institution. All accepted SBIR/STTR applications are evaluated for scientific and technical merit by an appropriate scientific peer review panel and by a national advisory council or board. All applications receiving a priority score compete for available SBIR/STTR set-aside funds on the basis of scientific and technical merit and commercial potential of the proposed research, program relevance, and program balance among the areas of research.
Contact the headquarters or regional office, as appropriate, for application deadlines.
Approval/Disapproval Decision Time
New Non-AIDS research applications: February 1, June 1 and October 1. For Renewal and Supplemental Non-AIDS research grant applications: March 1, July 1, and November 1. For all AIDS research grant applications: January 2, May 1, September 1. Research Career Development Award programs: February 1, June 1, October 1. Individual NRSAs: April 5, August 5, and December 5. Institutional NRSA: September 10. SBIR/STTR: April 1, August 1 and December 1.
A principal investigator may question the substantive or procedural aspects of the review of his/her application by communicating with the staff of the Institute. Final decisions on unresolved appeals are made with the advice of the National Advisory Allergy and Infectious Diseases Council.
Renewals of research grant support are by competitive application and review. The competitive application may request support for a segmental period of up to 5 years.
How are proposals selected?
The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit of the proposed approach for achieving the Phase II objectives; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation, originality, or societal importance of the proposed research; (5) the potential of the proposed research for commercial application; (6) the reasonableness of the budget requested for the work proposed; (7) the adequacy and suitability of the facilities and research environment; and (8) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment.
How may assistance be used?
Beginning with fiscal year 1998, the direct costs awarded in the first year to a research project grant resulting from a competing renewal application will be limited to no more than a 20 percent increase over the direct costs awarded in the last non-competing year of that grant. Research grants provide funds for salaries, equipment, supplies, and travel. They also afford the collateral benefits of enriching the training experience of research workers. Grantees are expected to be judicious in using these funds. The application for a research grant sets forth specific terms and conditions and requires the signatures of the principal investigator and an official authorized to sign for the institution. Scientists and institutions are under an obligation to expend grant funds prudently for the purposes stated in the application and award document. For Research Career Development Awards (RCDAs) the scientists must demonstrate an outstanding research potential for independent research in the sciences related to transplantation, immunology, allergies, and immunological diseases. For National Research Service Awards (NRSAs), each individual who receives NRSA support is obligated upon termination of the award to comply with certain service and payback provisions. SBIR Phase I grants (of approximately 6-months' duration) are to establish the technical merit and feasibility of a proposed research effort that may lead to a commercial product or process. Phase II grants are for the continuation of the research initiated in Phase I and which are likely to result in commercial products or processes. Only Phase I awardees are eligible to receive Phase II support. STTR Phase I grants (normally of 1-year duration) are to determine the scientific, technical, and commercial merit and feasibility of proposed cooperative effort that has potential for commercial application. Phase II funding is based on results of research initiated in Phase I and scientific and technical merit and commercial potential of the Phase II application.
What are the requirements after being awarded this opportunity?
Program reports are not applicable. Require quarterly expediture reports and yearly or grant period reports of expenditures. At the end of the project we expect final expenditure reports. Annual progress reports with informaiton on inventions and expenditures are required. Require quarterly expediture reports and yearly or grant period reports of expenditures. At the end of the project we expect final expenditure reports. Yearly and final progress reports are monitored.
In accordance with the provisions of 2 CFR 200, Subpart F - Audit Requirements, non-Federal entities that expend financial assistance of $750,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Non-Federal entities that expend less than $750,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in 2 CFR 200.503. In addition, grants and cooperative agreements are subject to inspection and audits by DHHS and other Federal government officials.
Grantees generally must retain financial and programmatic records, supporting documents, statistical records, and all other records that are required by the terms of a grant, or may reasonably be considered pertinent to a grant, for a period of 3 years from the date the annual FSR is submitted. For awards under SNAP (other than those to foreign organizations and Federal institutions), the 3-year retention period will be calculated from the date the FSR for the entire competitive segment is submitted. Those grantees must retain the records pertinent to the entire competitive segment for 3 years from the date the FSR is submitted to NIH. Foreign organizations and Federal institutions must retain records for 3 years from the date of submission of the annual FSR to NIH. See 45 CFR 74.53 and 92.42 for exceptions and qualifications to the 3-year retention requirement (e.g., if any litigation, claim, financial management review, or audit is started before the expiration of the 3-year period, the records must be retained until all litigation, claims, or audit findings involving the records have been resolved and final action taken). Those sections also specify the retention period for other types of grant-related records, including F&A cost proposals and property records. See 45 CFR 74.48 and 92.36 for record retention and access requirements for contracts under grants. In accordance with 45 Code of Federal Regulations, Part 74.53(e), the HHS Inspector General, the U.S. Comptroller General, or any of their duly authorized representatives have the right of timely and unrestricted access to any books, documents, papers, or other records of recipients that are pertinent to awards in order to make audits, examinations, excerpts, transcripts, and copies of such documents. This right also includes timely and reasonable access to a recipient’s personnel for the purpose of interview and discussion related to such documents. The rights of access are not limited to the required retention period, but shall last as long as records are retained.
Other Assistance Considerations
Formula and Matching Requirements
This program has no statutory formula.
This program has no matching requirements. no matching requirements.
This program has MOE requirements, see funding agency for further details. MOE requirements apply with allocations over $100 million.
Length and Time Phasing of Assistance
Research grant project periods average 4 years; they may not be extended beyond 7 years. (Project periods are generally composed of 1-year budget periods.) SBIR Normally, Phase I awards are for 6 months; normally, Phase II awards are for 2 years. STTR: Normally, Phase I awards are for 1 year; normally, Phase II awards are for 2 years. See the following for information on how assistance is awarded/released: Research grant project periods average 4 years; they may not be extended beyond 7 years. (Project periods are generally composed of 1-year budget periods.) SBIR Normally, Phase I awards are for 6 months; normally, Phase II awards are for 2 years. STTR: Normally, Phase I awards are for 1 year; normally, Phase II awards are for 2 years.
Who do I contact about this opportunity?
Regional or Local Office
Donna C. Perry 5601 Fishers Lane
Room 5E48, Bethesda, Maryland 20892 Email: email@example.com
(Project Grants) FY 14 $2,689,997,000; FY 15 est $2,762,301,000; and FY 16 est $2,917,357,000
Range and Average of Financial Assistance
from $2,500 to $6,395,901 and the average $426,165.
Regulations, Guidelines and Literature
Grants will be available under the authority of and administered in accordance with the PHS Grants Policy Statement and Federal regulations at 42 CFR 52 and 42 U.S.C. 241; Omnibus Solicitation of the Public Health Service for Small Business Innovation Research (SBIR) Grant and Cooperative Agreement Applications. Omnibus Solicitation of the National Institutes of Health for Small Business Technology Transfer (STTR) Grant Applications.
Examples of Funded Projects